CLASS II ONGOING Drug recall · Reported 30 Oct 2024 · FDA Enforcement Report
AK Forte Ortiga y Omega 3 Cont recalled by C & A Naturistics
C & A Naturistics is recalling AK Forte Ortiga y Omega 3 Cont, distributed nationwide in the US. The recall was initiated on 8 Oct 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0024-2025
- FDA event ID
- 95520
- Recalling firm
- C & A Naturistics, National City, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Oct 2024
- FDA classified
- 22 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 8 Oct 2024 | Recall initiated by company | |
| 22 Oct 2024 | Classified by FDA | +14 days |
| 30 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Product as listed by the FDA
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Which lots are affected?
All Lots
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.